NCT03317951: CardioCare MV

Investigation of a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease

Status unknown NA Last updated 29 November 2019

What this trial tests

NA trial testing Novel integrated care concept (NICC) in Heart Failure in 964 participants. Status unknown.

Timeline

1 December 2017

Primary endpoint
30 September 2020

30 September 2020

Quick facts

Lead sponsor	University Medical Center Rostock
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	964
Start date	1 December 2017
Primary completion	30 September 2020
Estimated completion	30 September 2020
Sites	1 location across Germany

Drugs / interventions tested

• Novel integrated care concept (NICC)
• Standard care — full drug profile →

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Treatment Resistant Hypertension — all drugs for Treatment Resistant Hypertension →

Sponsor

University Medical Center Rostock

Who can join

18 and older, any sex, with Heart Failure or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cardiovascular diseases are the number 1 cause of death globally and represent a major economic burden on health care systems. The investigators have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a call center, an integrated care network including in- and outpatient care providers and guideline therapy for patients with heart failure (HF), atrial fibrillation (AF) or therapy resistant hypertension (TRH). The aim of the study is to show that NICC is preferable over guideline therapy alone. We aim at including approximately 890 patients. Patients could be enrolled either directly at the Care-Center (location: University Hospital of Rostock) or at one of the advanced treatments rooms of the Care-Center (outpatient cardiological specialist practices).

The ethics commission's statement of the University of Rostock is available for amendment 2 since 20.08.2019 at the number A2017-0117.

Publications & conference data

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

1. Disease management interventions for heart failure.
   Takeda A, Martin N, Taylor RS, Taylor SJ. · · 2019 · cited 91× · PMID 30620776 · DOI 10.1002/14651858.cd002752.pub4
2. A novel integrated care concept (NICC) versus standard care in the treatment of chronic cardiovascular diseases: protocol for the randomized controlled trial CardioCare MV.
   Schmidt C, Öner A, Mann M, Krockenberger K, et al · · 2018 · cited 9× · PMID 29458404 · DOI 10.1186/s13063-018-2502-1
3. Comparison of telemonitoring combined with intensive patient support with standard care in patients with chronic cardiovascular disease - a randomized clinical trial.
   Öner A, Dittrich H, Arslan F, Hintz S, et al · · 2023 · cited 4× · PMID 36631889 · DOI 10.1186/s40001-023-00991-1
4. Statistical analysis plan for the randomized controlled trial CardioCare MV investigating a novel integrated care concept (NICC) for patients suffering from chronic cardiovascular disease.
   Ziegler A, Mann M, Brandewiede B, Dittrich H, et al · · 2020 · cited 3× · PMID 32014033 · DOI 10.1186/s13063-020-4052-6