NCT05104658: HeRTA

Heart Rehabilitation for All

Active, enrolled NA Last updated 26 August 2024

What this trial tests

NA trial testing Patient-targeted rehabilitation offers in Ischemic Heart Disease in 218 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 April 2022

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Center for Clinical Research and Prevention
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	218
Start date	1 April 2022
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across Denmark

Drugs / interventions tested

• Patient-targeted rehabilitation offers

Conditions studied

• Ischemic Heart Disease — all drugs for Ischemic Heart Disease →
• Cardiac Valve Surgery — all drugs for Cardiac Valve Surgery →
• Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →
• Heart Failure — all drugs for Heart Failure →

Sponsor

Center for Clinical Research and Prevention

Who can join

18 and older, any sex, with Ischemic Heart Disease or Cardiac Valve Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Today, 50 % of cardiac patients do not participate in cardiac rehabilitation due difficulties in navigating and accessing rehabilitation activities.

HeRTA is a partnership project involving Center for Clinical Research and Prevention (CCRP), Hvidovre Hospital, Rehabilitation Center Albertslund and Copenhagen (municipalities), the Danish Heart Association, and local sports associations. A patient advisory board participate throughout the project to ensure a continued focus on patient interests.

The overall aim of HeRTA is to develop and test the feasibility of a new, sustainable model for rehabilitation supporting patients to take part in rehabilitation and promoting life-long activity for all patients with heart disease. To ensure equal access to rehabilitation some activities are open to all patients, while others are tailored specifically to patients with vulnerability.

The project unfolds in three phases: Development (1. January 1. 2020 - 14. November 2021): Partners and patients co-create content and procedures; Feasibility (15. November 2021 - 31. July 2023): The feasibility of the model is tested, and promising components are identified; Long-term follow-up and implementation (1. August 2023 - 31. December 2025): Long term effects are investigated and promising components are tested in new settings.

During the feasibility phase the investigators will examine whether the intervention activities are feasible, acceptable, and may have positive effects for patients with heart disease. The investigators use qualitative data on implementation and acceptability of intervention among partners and patients. An randomisered controlled trial (RCT) component will assess effects on patient participation rates, health, physical activity level, and life quality. Data is collected from practitioners and patients through focus groups, observations, field notes, questionnaires, and interviews.

Results will point to:

* innovative ways to organize integrated rehabilitation pathways.
* approaches to ensuring rehabilitation targeted at patient needs.

Publications & conference data

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

1. Heart Rehabilitation for All (HeRTA): Protocol for a feasibility study and pilot randomized trial.
   Birke H, Foxvig I, Burns K, Toft U, et al · · 2022 · cited 3× · PMID 35714121 · DOI 10.1371/journal.pone.0270159