RELIf-CHF: Longterm treatment with ivabradine in ambulatory patients with chronic systolic heart failure

RELIf-CHF: Longterm treatment with ivabradine in ambulatory patients with chronic systolic heart failure - a prospective non-interventional study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN07436597

Enrollment

2250

Registered

2014-04-29

Start date

2014-03-17

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic systolic heart insufficiency/cardiology Circulatory System

Interventions

Participating physicians receive a spiral folder including documents for 3 patients. Data will be collected at 5 examinations during routine medical treatment. Following data will be c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Ambulant patients with chronic systolic heart insufficiency, who are treated according to the indication of Procoralan®. This includes: 1. Patients with chronic heart failure NYHA II to IV with systolic dysfunction 2. Patients with chronic heart failure with sinus rhythm and whose heart rate is = 75 bpm in combination with standard therapy in-/excluding beta-blocker therapy

Exclusion criteria

Exclusion criteria: All contraindications listed in the Summary of Product Characteristics (SmPC)

Design outcomes

Primary

Measure	Time frame
1. Use and tolerance of Procoralan® in accordance with the SmPC 2. The effect of treatment on symptoms of chronic systolic heart failure in ambulatory patients non-interventional under routine daily conditions Measurement of outcomes (efficacy and safety under medical routine treatment) at the following 5 time points: Baseline (U1)/start of therapy, after 4 weeks (U2), after 4 months (U3), after 8 month (U4), after 12 month (U5)	—

Measure

Time frame

1. Use and tolerance of Procoralan® in accordance with the SmPC 2. The effect of treatment on symptoms of chronic systolic heart failure in ambulatory patients non-interventional under routine daily conditions Measurement of outcomes (efficacy and safety under medical routine treatment) at the following 5 time points: Baseline (U1)/start of therapy, after 4 weeks (U2), after 4 months (U3), after 8 month (U4), after 12 month (U5)

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Secondary

Measure	Time frame
1. Changes in heart frequency during treatment with Procoralan® 2. Therapy influence on symptom control: NYHA classification, decompensation 3. Influence of therapy on life quality and patients´ hospitalisation rate 4. Assessment of possible correlations of Procoralan® therapy and existing (cardiovascular) concomitant therapy 5. Adding of knowledge regarding general tolerance and specific adverse drug reactions (ADR) under Procoralan® therapy 6. General assessment of Procoralan® therapy in patients with chronic systolic heart insufficiency under existing medical concomitant therapy for heart insufficiency	—

Measure

Time frame

1. Changes in heart frequency during treatment with Procoralan® 2. Therapy influence on symptom control: NYHA classification, decompensation 3. Influence of therapy on life quality and patients´ hospitalisation rate 4. Assessment of possible correlations of Procoralan® therapy and existing (cardiovascular) concomitant therapy 5. Adding of knowledge regarding general tolerance and specific adverse drug reactions (ADR) under Procoralan® therapy 6. General assessment of Procoralan® therapy in patients with chronic systolic heart insufficiency under existing medical concomitant therapy for heart insufficiency

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026