|- candidate number||5472|
|- NTR Number||NTR1729|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-mrt-2009|
|- Secondary IDs||2008B083 Nederlandse Hartstichting/Netherlands Heart Foundation|
|- Public Title||Long term care for Heart Failure patients; HF clinics versus primary care.|
|- Scientific Title||Heart Failure clinics versus primary care in the long-term follow-up of patients with chronic heart failure: COACH-2.|
|- hypothesis||Long-term follow-up, after initial uptitration to optimal pharmacolgical and non-pharmacological treatment in the HF clinic, provided in primary care, is equally effective compared to long-term follow-up in the HF clinic in terms of medication use (guideline adherence and patient compliance).|
|- Healt Condition(s) or Problem(s) studied||Heart failure, Chronic|
|- Inclusion criteria||Patients are eligible when they;|
1. Have symptomatic, systolic HF (NYHA II-III);
2. Are visiting the Heart Failure clinic of one of the participating centres;
3. Have HF with evidence for structural underlying ventricular dysfunction (LVEF<40%);
4. Are up titrated to optimal pharmacological treatment (notably use of adequate dosages of ACE-inhibitors/ARBs and beta blockers);
5. Are in a stable condition; no hospital admissions in the previous month, no visits at the emergency unit for decompensation in the previous month, no unplanned medication changes in the previous month;
6. Have received information and education on heart failure and the required life style changes following a pre-specified protocol;
7. Are aged above 18 years.
|- Exclusion criteria||Patients will be excluded from the study when;|
1. Patient management by a cardiologist planned for diagnostics or treatment is needed;
2. The patient has restrictions that render patients to fill in data collection materials (non-mastering of the Dutch language);
3. The patient has a life expectancy shorter than 6 months;
4. The patient has a current psychiatric disorder as documented in the medical record.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||14-apr-2009|
|- planned closingdate||14-apr-2013|
|- Target number of participants||200|
|- Interventions||HF patients in both intervention groups will be followed-up according
to the Dutch Multidisciplinary Guideline on Chronic Heart Failure.|
|- Primary outcome||1. Guideline Adherence with Pharmacologicial treatment of Heart Failure;|
2. Patient compliance with medication.
|- Secondary outcome||1. Guideline Adherence Optimal Dose;|
2. Number of hospital readmissions;
4. Patient compliance with lifestyle recommendations on diet, fluid and weighing;
5. Quality of Life;
6. Guideline Adherence devices
|- Timepoints||Baseline and End of Study.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. M.L.A. Luttik|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M.L.A. Luttik|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Department of Cardiology|
(Source(s) of Monetary or Material Support)
|Dutch Heart Foundation (Nederlandse Hartstichting)|
|- Brief summary||Background: |
Since the prevalence of HF is still growing, it is now foreseen that the HF clinics will become overloaded and will not be able to treat and monitor all HF patients for longer time periods after initial management of new patients. At this time it is unclear whether and when patients can be discharged from the HF clinic to be further managed in primary care.
The aim of the current study is to determine whether long-term follow-up in primary care, under the condition of initial optimization of pharmacological and non-pharmacological treatment at the specialized HF clinic, is equally effective as long term follow up at the specialized HF clinic in terms of guideline adherence and patient compliance in patients with HF.
Two-hundred patients will be randomly assigned to follow-up in primary care or to follow-up within the heart failure clinic. Patients are eligible to participate when patients (1) are in a stable condition, (2) are optimally up-titrated on medication and, (3) have received optimal education and counselling on pre-specified issues regarding HF and its treatment. Furthermore, close cooperation between secondary and primary care in terms of back referral to or consultation of the HF clinic will be provided.
Primary outcome will be medication use in terms of prescribed medication and patient compliance with medication after 12 months. Secondary outcomes measures will be readmission rate, mortality, quality of life and patient compliance with other life style changes.
Results of the study will provide an answer to the question if long-term follow-up of HF patients in primary care is a feasible and equally effective option compared to long-term.
Follow up within the HF clinic. This insight is needed in order to create and assure optimal long-term care for HF patients.
|- Main changes (audit trail)|
|- RECORD||18-mrt-2009 - 14-sep-2009|