deltatrials
Completed OBSERVATIONAL NCT01057004

EVIdence Based TreAtment - Heart Failure (EVITA-HF) (EVITA-HF)

Sponsor: Stiftung Institut fuer Herzinfarktforschung

Conditions Heart Failure
Updated 10 times since 2017 Last updated: Jun 23, 2016 Started: Feb 28, 2009 Primary completion: Dec 31, 2015 Completion: Dec 31, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01057004, this observational or N/A phase trial focuses on Heart Failure and remains completed. Sponsored by Stiftung Institut fuer Herzinfarktforschung, it has been updated 10 times since 2009, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Study Description(click to expand)

Cardiac insufficiency is the main or secondary diagnosis of 10% of all hospitalised patients. Due to the age-structure of the population and to the increased life expectancy after myocardial infarction prevalence is increasing. Even though prognosis in patients with established heart failure has been improved it remains serious, with an average survival rate of 50% after 4 years. Approximately 2% of all expenses in health care are caused by cardiac insufficiency, the most expensive being the hospitalization phase. The rehospitalisation rate after the first hospital stay is 50% within 6 months. By optimal, guideline-adjusted therapy during hospital- and post-hospital-stay the rehospitalisation rate could be reduced by 50%. But our knowledge concerning therapies is based on study results, which are generated with selected patients under controlled study conditions. Thus it is necessary to collect data on the development of therapy, the successes as well as the complications in clinical everyday life. Results concerning the quality of therapies are required and measures are needed that will contribute to quality assurance and improvement. Due to these reasons EVITA was initiated with the following objectives, aims, structure, and organization form: The register will not substitute randomized, controlled, multi-center clinical trials (RCT) that have a...

Cardiac insufficiency is the main or secondary diagnosis of 10% of all hospitalised patients. Due to the age-structure of the population and to the increased life expectancy after myocardial infarction prevalence is increasing. Even though prognosis in patients with established heart failure has been improved it remains serious, with an average survival rate of 50% after 4 years. Approximately 2% of all expenses in health care are caused by cardiac insufficiency, the most expensive being the hospitalization phase. The rehospitalisation rate after the first hospital stay is 50% within 6 months. By optimal, guideline-adjusted therapy during hospital- and post-hospital-stay the rehospitalisation rate could be reduced by 50%.

But our knowledge concerning therapies is based on study results, which are generated with selected patients under controlled study conditions. Thus it is necessary to collect data on the development of therapy, the successes as well as the complications in clinical everyday life. Results concerning the quality of therapies are required and measures are needed that will contribute to quality assurance and improvement. Due to these reasons EVITA was initiated with the following objectives, aims, structure, and organization form:

The register will not substitute randomized, controlled, multi-center clinical trials (RCT) that have a defined prospective research question. Such randomized studies investigate the "efficacy" of a therapy, i.e. a clinical effect under experimental conditions. In contrast, registers investigate the transferability of RCT results to the daily routine within hospital, the so called "effectiveness". Both study types are complementary and are needed for a judgment of the clinical efficiency as well as of security aspects and possible adverse reactions. Furthermore EVITA should function as an idea supplier and should coordinate possible future studies. Other important tasks of the register are: (i) the establishment of recommendations for an optimal medicinal therapy (OMT) as well as for ICD- and CRT-treatment; (ii) the establishment of quality assurance measures, including monitoring of new therapy. Every 6 months each study center receives a complete overview concerning the centers own data in comparison with the data supplied by other centers.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~May 2020 · 23 months · monthly snapshotCompleted~May 2020 – ~Jan 2021 · 8 months · monthly snapshotCompleted~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotCompleted~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2025 — Present [monthly]

    Completed

  3. Sep 2024 — Sep 2025 [monthly]

    Completed

  4. Jul 2024 — Sep 2024 [monthly]

    Completed

  5. Oct 2021 — Jul 2024 [monthly]

    Completed

Show 5 earlier versions
  1. Jan 2021 — Oct 2021 [monthly]

    Completed

  2. May 2020 — Jan 2021 [monthly]

    Completed

  3. Jun 2018 — May 2020 [monthly]

    Completed

  4. Apr 2018 — Jun 2018 [monthly]

    Completed

    Phase: NANone

  5. Jan 2017 — Apr 2018 [monthly]

    Completed NA

    First recorded

Feb 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Stiftung Institut fuer Herzinfarktforschung
  • Vifor Pharma
Data source: Stiftung Institut fuer Herzinfarktforschung

For direct contact, visit the study record on ClinicalTrials.gov .