NCT04394754 is a NA clinical trial of BodyPort in Congestive Heart Failure, sponsored by Yale University.

Who is sponsoring NCT04394754?

NCT04394754 is sponsored by Yale University.

What drugs are being tested in NCT04394754?

Interventions in NCT04394754: BodyPort, Noom, Conversa.

What condition does NCT04394754 study?

NCT04394754 studies Congestive Heart Failure.

Is NCT04394754 still recruiting?

NCT04394754 is currently completed. Last updated 18 May 2023.

Are results published for NCT04394754?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-05-18 · How we verify

NCT04394754

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure

Completed NA Results posted Last updated 18 May 2023

What this trial tests

NA trial testing BodyPort in Congestive Heart Failure in 182 participants. Completed in 1 December 2021.

Timeline

21 September 2020

Primary endpoint
20 September 2021

1 December 2021

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	182
Start date	21 September 2020
Primary completion	20 September 2021
Estimated completion	1 December 2021
Sites	1 location across United States

Drugs / interventions tested

BodyPort
Noom
Conversa

Conditions studied

Congestive Heart Failure — all drugs for Congestive Heart Failure →

Sponsor

Yale University

Who can join

Adults 18 to 79, any sex, with Congestive Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Quality of Life at 90 Days Post Enrollment Primary · Day 90 after enrollment

Assessed by the change in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) survey between baseline scoring (at enrollment) and at 90 days post-enrollment. This survey is a 23 item self-administered instrument used to quantify a patient's perception of health status. For each domain reported, an overall summary scored is derived and transformed to a score range of 0-100. The Total Symptom score is the mean of the Symptom Frequency and Symptom Burden scores. The Overall Summary Score is the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation Scores.

Physical Limitation

Group	Value	95% CI
Control	-4.2	-14.6 – 4.2
BodyPort	-4.2	-12.5 – 4.2
Noom	0	-4.2 – 10.4
Conversa	-4.2	-16.7 – 0

Symptom Stability

Group	Value	95% CI
Control	0	-25 – 0
BodyPort	0	-25 – 0
Noom	0	-25 – 25
Conversa	0	0 – 0

Symptom Frequency

Group	Value	95% CI
Control	-2.1	-13.5 – 10.4
BodyPort	0	-8.3 – 10.4
Noom	0	-4.2 – 18.8
Conversa	3.1	-4.2 – 12.5

Symptom Burden

Group	Value	95% CI
Control	0	-8.3 – 8.3
BodyPort	0	-8.3 – 16.7
Noom	8.3	0 – 16.7
Conversa	0	-8.3 – 16.7

Total Symptom Score

Group	Value	95% CI
Control	-1	-13.5 – 7.8
BodyPort	0	-4.2 – 14.6
Noom	4.2	-1 – 16.7
Conversa	1	-6.2 – 12.5

Self-Efficacy

Group	Value	95% CI
Control	0	0 – 12.5
BodyPort	0	0 – 12.5
Noom	0	-12.5 – 12.5
Conversa	0	0 – 12.5

Quality of Life

Group	Value	95% CI
Control	8.3	-16.7 – 25
BodyPort	8.3	-8.3 – 25
Noom	4.2	-8.3 – 16.7
Conversa	0	-8.4 – 16.7

Social Limitation

Group	Value	95% CI
Control	0	-16.7 – 8.3
BodyPort	0	-12.5 – 18.8
Noom	0	-6.3 – 25
Conversa	0	-12.5 – 6.3

Change in Quality of Life at 180 Days Post Enrollment Secondary · 180 days post enrollment

Assessed by the change in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) survey between day 90 post enrollment and at day 180 post enrollment. This survey is a 23 item self-administered instrument used to quantify a patient's perception of health status. For each domain reported, an overall summary scored is derived and transformed to a score range of 0-100. The Total Symptom score is the mean of the Symptom Frequency and Symptom Burden scores. The Overall Summary Score is the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation Scores. The Clinic

Physical Limitation

Group	Value	95% CI
Control	-4.2	-12.5 – 4.2
BodyPort	-8.3	-18.8 – 0
Noom	-2.1	-10.4 – 8.3
Conversa	-2.1	-8.3 – 8.3

Symptom Stability

Group	Value	95% CI
Control	0	-25 – 0
BodyPort	0	0 – 0
Noom	0	-25 – 0
Conversa	0	-25 – 0

Symptom Frequency

Group	Value	95% CI
Control	0	-8.3 – 8.3
BodyPort	0	-8.3 – 4.2
Noom	6.3	-4.2 – 29.2
Conversa	0	-4.2 – 12.5

Symptom Burden

Group	Value	95% CI
Control	0	-8.3 – 16.7
BodyPort	0	-16.7 – 16.7
Noom	0	-8.3 – 16.7
Conversa	0	-16.7 – 8.3

Total Symptom Score

Group	Value	95% CI
Control	0	-8.3 – 10.4
BodyPort	0	-10.4 – 6.2
Noom	7.3	0 – 18.7
Conversa	0	-18.8 – 10.4

Self- Efficacy

Group	Value	95% CI
Control	0	0 – 12.5
BodyPort	0	0 – 12.5
Noom	0	0 – 12.5
Conversa	0	0 – 12.5

Quality of Life

Group	Value	95% CI
Control	8.3	0 – 16.7
BodyPort	0	-8.3 – 8.3
Noom	0	-16.7 – 16.7
Conversa	0	-8.3 – 25

Social Limitation

Group	Value	95% CI
Control	0	-9.4 – 12.5
BodyPort	0	-12.5 – 12.5
Noom	-3.1	-18.8 – 5.2
Conversa	0	-12.5 – 16.7

Number of Participants With Hospital Admission at 90 Days Post Enrollment Secondary · 90 days post enrollment

Via medical record review. Number of patients with a hospital admission between enrollment to day 90 post enrollment.

Participants with hospital admission

Group	Value	95% CI
Control	11
BodyPort	16
Noom	14
Conversa	17

Participants with hospital admission related to congestive heart failure (CHF)

Group	Value	95% CI
Control	4
BodyPort	6
Noom	2
Conversa	3

Number of Participants With Hospital Admission at 180 Days Post Enrollment Secondary · 180 days post enrollment

Via medical record review. This measure is calculated as the number of participants with a hospital admission from day 90 to day 180 post enrollment.

Participants with hospital admission

Group	Value	95% CI
Control	10
BodyPort	15
Noom	15
Conversa	14

Participants with hospital admission related to CHF

Group	Value	95% CI
Control	3
BodyPort	5
Noom	3
Conversa	4

Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment Secondary · 90 days post enrollment

Number of patients having documented prescription of all of the following medication classes between enrollment and day 90 post enrollment: beta blockers, angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARBs)/angiotensin receptor-neprilysin inhibitors (ARNI), sodium/glucose cotransporter-2 inhibitors (SGLT2i) and aldosterone receptor antagonists (MRAs); assessed via Surescripts data collection.

Beta-blocker

Group	Value	95% CI
Control	42
BodyPort	39
Noom	41
Conversa	42

ACEi/ARB/ARNI

Group	Value	95% CI
Control	32
BodyPort	36
Noom	33
Conversa	30

MRA

Group	Value	95% CI
Control	25
BodyPort	25
Noom	26
Conversa	21

SGLT2i

Group	Value	95% CI
Control	15
BodyPort	13
Noom	18
Conversa	17

Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment Secondary · 180 days post enrollment

Number of patients having documented prescription of all of the following medication classes between day 90 post enrollment and day 180 post enrollment: beta blockers, angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARBs)/angiotensin receptor-neprilysin inhibitors (ARNI), sodium/glucose cotransporter-2 inhibitors (SGLT2i) and aldosterone receptor antagonists (MRAs); assessed via Surescripts data collection.

Beta Blocker

Group	Value	95% CI
Control	40
BodyPort	38
Noom	40
Conversa	40

ACEi/ARB/ARNI

Group	Value	95% CI
Control	34
BodyPort	35
Noom	32
Conversa	32

MRA

Group	Value	95% CI
Control	23
BodyPort	24
Noom	24
Conversa	25

SGLT2i

Group	Value	95% CI
Control	17
BodyPort	13
Noom	17
Conversa	17

Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment Secondary · 90 days post enrollment

Via medical record review. Number of participants with an emergency department visit between enrollment and day 90 post enrollment.

Participants with ED visit

Group	Value	95% CI
Control	10
BodyPort	12
Noom	10
Conversa	14

Participants with ED visit related to CHF

Group	Value	95% CI
Control	4
BodyPort	3
Noom	4
Conversa	4

Number of Participants With Emergency Department Visits at 180 Days Post Enrollment Secondary · 180 days post enrollment

Via medical record review. Number of participants with an emergency department visit between day 90 and day 180 post enrollment.

Participants with ED visit

Group	Value	95% CI
Control	8
BodyPort	12
Noom	13
Conversa	13

Participants with ED visit related to CHF

Group	Value	95% CI
Control	4
BodyPort	3
Noom	4
Conversa	1

Number of Participants With Acute Kidney Injury (AKI) Development at 90 Days Post Enrollment Secondary · 90 days post enrollment

Via medical record review, defined as an increase in serum creatinine by 50% over baseline (pre-enrollment creatinine) at any point between enrollment day 90 post enrollment.

Group	Value	95% CI
Control	4
BodyPort	6
Noom	2
Conversa	6

Number of Participants With Acute Kidney Injury (AKI) Development at 180 Days Post Enrollment Secondary · 180 days post enrollment

Via medical record review, defined as an increase in serum creatinine by 50% over baseline (pre-enrollment creatinine) at any point between day 90 and day 180 post enrollment.

Group	Value	95% CI
Control	3
BodyPort	2
Noom	3
Conversa	3

Mortality Rate at 90 Days Post Enrollment Secondary · 90 days post enrollment

Via medical record review. Number of deaths between enrollment and 90 days post enrollment.

Group	Value	95% CI
Control	0
BodyPort	0
Noom	0
Conversa	1

Mortality Rates at 180 Days Post Enrollment Secondary · 180 days post enrollment

Via medical record review. Number of deaths between day 90 and day 180 post enrollment.

Group	Value	95% CI
Control	1
BodyPort	2
Noom	0
Conversa	1

Sponsor's own description

The purpose of this study is to determine the efficacy of three novel digital health technologies versus usual care in the management of congestive heart failure, as assessed by a primary outcome of improvement in quality of life, and a variety of secondary outcomes that include metrics measuring patient and provider satisfaction, clinical efficiency, and patient outcomes.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Impact of Digital Health Technology on Quality of Life in Patients With Heart Failure.
Victoria-Castro AM, Martin ML, Yamamoto Y, Melchinger H, et al · · 2024 · cited 16× · PMID 37943227 · DOI 10.1016/j.jchf.2023.09.022
Pragmatic randomized trial assessing the impact of digital health technology on quality of life in patients with heart failure: Design, rationale and implementation.
Victoria-Castro AM, Martin M, Yamamoto Y, Ahmad T, et al · · 2022 · cited 7× · PMID 35822275 · DOI 10.1002/clc.23848
Pragmatic Randomized Trial Assessing the Impact of Digital Health Technology on Quality of Life in Patients With Congestive Heart Failure: Design and Rationale
Victoria-Castro AM, Martin ML, Yamamoto Y, Ahmad T, et al · · 2021 · DOI 10.1101/2021.11.19.21266591

Verify or expand the search:

Other recruiting trials for Congestive Heart Failure

Currently open trials in the same condition.

NCT07008365 — The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure · Phase 3 · recruiting
NCT06526884 — Quasi-Randomized Evaluation of the UCLA Next Day Clinic (NDC) · NA · active not recruiting
NCT06495892 — PVP-Guided Decongestive Therapy in HF 2 · Phase 4 · recruiting
NCT06374277 — Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence · NA · recruiting
NCT05971225 — Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe) · NA · recruiting

Other Yale University trials

Trials by the same sponsor.

NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
NCT04910984 — Developing a Chatbot to Promote HIV Testing · NA · not yet recruiting
NCT07458087 — Accuracy of the Accuro 3S · NA · not yet recruiting
NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04394754 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 18 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04394754.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing