NCT04738279

The CASCADE HF Soft Launch and Calibration Phase I and II

Completed Phase 2, PHASE3 Results posted Last updated 3 October 2023

What this trial tests

Phase 2, PHASE3 trial testing Non-Invasive Continuous Remote Patient Monitoring in Heart Failure in 20 participants. Completed in 30 October 2021.

Timeline

14 December 2020

Primary endpoint
30 October 2021

30 October 2021

Quick facts

Lead sponsor	Endeavor Health
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	other
Enrollment	20
Start date	14 December 2020
Primary completion	30 October 2021
Estimated completion	30 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Non-Invasive Continuous Remote Patient Monitoring
• Affective Analysis of Participant Response to Continuous Remote Patient Monitoring

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Endeavor Health — full company profile →

Who can join

18 and older, any sex, with 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.

Attrition Rate Primary · 30 days from patient discharge date

Drop out from study

Group	Value	95% CI
Phase I: Soft Launch (120 Days)	1
Phase II: Calibration (210 Days)	2

Enrollment Rate Primary · Through study completion, an average of 30 days for each patient

Enrollment rate for entire patient cohort

Group	Value	95% CI
Phase I: Soft Launch (120 Days)	5
Phase II: Calibration (210 Days)	15

Number of Participants With Diuretic Escalation Secondary · 30 days from patient discharge date

Frequency of augmenting diuretic dosage as prescribed by the cardiologist to the patient.

Group	Value	95% CI
Phase I: Soft Launch (120 Days)	2
Phase II: Calibration (210 Days)	9

30-day Readmission Secondary · 30 days from patient discharge date

30-day readmission to hospital

Group	Value	95% CI
Phase I: Soft Launch (120 Days)	2
Phase II: Calibration (210 Days)	2

Sponsor's own description

Invasive telemonitoring has shown promising results in reducing readmissions and health service utilization, and improving patient outcomes; however, such evidence is lacking for non-invasive telemonitoring. Our proposal is to deploy a wearable solution that predicts physiological perturbation comparable to invasive devices and to perform continuous remote patient monitoring; this will be connected to a structured, cascading, escalation pathway involving home health nurses, advanced practitioner providers, specialists, and surgeons, and has the potential to transform care management in the post-discharge period, where patients are the most vulnerable for readmission.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Trends of Decentralized Clinical Trials Using Digital Technology for Decentralization
   Sato T, Mizumoto S, Ota M, Shikano M. · · 2022 · DOI 10.2139/ssrn.4243284