Heart Failure PatientsNCT04587947
Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study
A study testing sacubitril/ valsartan in people with Heart Failure Patients, run by St. Josefs-Hospital Wiesbaden GmbH at 1 site in Germany.
Trial summary
Sacubitril/valsartan is an angiotensin receptor neprilysin inhibitor with the ability to reduce myocardial hypertrophy, cardiac remodeling and cardiorenal fibrosis. The compound is also believed to have antiarrhythmic properties as it has been shown to significantly reduce ventricular arrhythmias in patients with… Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Heart Failure Patients
- What is being tested?
- sacubitril/ valsartan
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2020to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic severe heart failure with reduced ejection fraction (LVEF ≤40%,)
- Age > 20 years
- Consent capacity
- Sinus rhythm
- Suitable for a drug conversion from AT1/ACE inhibitors to sacubitril/ valsartan
Who cannot join
- Age < 18 years
- Atrial fibrillation
- Pregnancy
- Lack of consent capacity
- Contraindications for a therapy with sacubitril/ valsartan
Trial locations and contacts
1 site in 1 country.
About this study
Sacubitril/valsartan is an angiotensin receptor neprilysin inhibitor with the ability to reduce myocardial hypertrophy, cardiac remodeling and cardiorenal fibrosis. The compound is also believed to have antiarrhythmic properties as it has been shown to significantly reduce ventricular arrhythmias in patients with implantable cardioverter defibrillators.
Patients suffering from heart failure with reduced ejection fraction show impaired heart rate variability, knowing that in these patients such impairment is highly associated with an increased risk of sudden cardiac death.
Read more
In its pivotal study, sacubitril/valsartan demonstrated a significant advantage over enalapril in terms of cardiovascular mortality and rehospitalization.
Against this background, this study was designed to analyze the largely unknown electrophysiological effects of sacubitril/valsartan on the autonomic cardiac nervous system by determining heart rate variability.
- Conditions
- Heart Failure Patients
- Being tested
- sacubitril/ valsartan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacubitril/ valsartanDrug
Heart rate variability measurement is carried out by means of a 12-channel ECG for 30 minutes in supine position followed by 10 minutes in standing position. All parameters, including blood values and echocardiographic parameters are assessed before beginning of sacubitril/ valsartan therapy and 3 months after starting treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart rate variability
Changes in heart rate variability after 3 months of treatment with sacubitril/ valsartan
Measured: 24 months
Changes in left ventricular ejection fraction (%)
Changes in left ventricular ejection fraction (%) assessed by transthoracic echocardiogramChanges in echocardiographic parameters (left ventricular parameters)
Measured: 24 months
Changes in mitral insufficiency grade
Changes in mitral insufficiency grade assessed by transthoracic echocardiogram
Measured: 24 months
Changes in serum NT-proB-Type natriuretic peptide (ng/l)
Changes in laboratory parameters (serum NT-proB-Type natriuretic peptide (ng/l)
Measured: 24 months
Changes in Serum creatinine level (mg/dl)
Changes in laboratory parameters (Serum creatinine level (mg/dl)
Measured: 24 months
Changes in glomerular filtration rate (ml/min)
Changes in laboratory parameters (glomerular filtration rate ml/min)
Measured: 24 months
Changes in serum potassium level (mmol/l)
Changes in laboratory parameters (glomerular filtration rate ml/min)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Apr 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Heart rate variability measurement is carried out by means of a 12-channel ECG for 30 minutes in supine position followed by 10 minutes in standing position. All parameters, including blood values and echocardiographic parameters are assessed before beginning of sacubitril/ valsartan therapy and 3 months after starting treatment.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587947
- Sponsor's protocol ID
- Entresto
- Status last verified
- Sep 2024
- First submitted
- 24 Jun 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boehmer AA, Schubert T, Rothe M, Keim C, Wiedenmann L, Ruckes C, von Stuelpnagel L, Theurl F, Schreinlechner M, Dobre BC, Kaess BM, Bauer A, Ehrlich JR. Angiotensin Receptor-Neprilysin Inhibitor Is Associated With Improved Cardiac Autonomic Function in Heart Failure. J Am Heart Assoc. 2024 Aug 6;13(15):e033538. doi: 10.1161/JAHA.123.033538. Epub 2024 Jul 31.
PubMed 39082399
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study
- ClinicalTrials.gov ID
- NCT04587947
- Acronym / sponsor ID
- Entresto
- Conditions
- Heart Failure Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbHUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sacubitril/valsartan is an angiotensin receptor neprilysin inhibitor with the ability to reduce myocardial hypertrophy, cardiac remodeling and cardiorenal fibrosis. The compound is also believed to have antiarrhythmic properties as it has been shown to significantly reduce ventricular arrhythmias in patients with implantable cardioverter defibrillators.
Patients suffering from heart failure with reduced ejection fraction show impaired heart rate variability, knowing that in these patients such impairment is highly associated with an increased risk of sudden cardiac death.
In its pivotal study, sacubitril/valsartan demonstrated a significant advantage over enalapril in terms of cardiovascular mortality and rehospitalization.
Against this background, this study was designed to analyze the largely unknown electrophysiological effects of sacubitril/valsartan on the autonomic cardiac nervous system by determining heart rate variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Heart rate variability measurement is carried out by means of a 12-channel ECG for 30 minutes in supine position followed by 10 minutes in standing position. All parameters, including blood values and echocardiographic parameters are assessed before beginning of sacubitril/ valsartan therapy and 3 months after starting treatment.
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with symptomatic severe heart failure with reduced ejection fraction (LVEF ≤40%,)
- Age > 20 years
- Consent capacity
- Sinus rhythm
- Suitable for a drug conversion from AT1/ACE inhibitors to sacubitril/ valsartan
Key exclusion criteria (5 listed)
- Age < 18 years
- Atrial fibrillation
- Pregnancy
- Lack of consent capacity
- Contraindications for a therapy with sacubitril/ valsartan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacubitril/ valsartanHeart rate variability measurement is carried out by means of a 12-channel ECG for 30 minutes in supine position followed by 10 minutes in standing position. All parameters, including blood values and echocardiographic parameters are assessed before beginning of sacubitril/ valsartan therapy and 3 months after starting treatment | Drug | – |
Primary outcome
Changes in heart rate variability
Time frame: 24 months
Changes in heart rate variability after 3 months of treatment with sacubitril/ valsartan
Changes in left ventricular ejection fraction (%)
Time frame: 24 months
Changes in left ventricular ejection fraction (%) assessed by transthoracic echocardiogramChanges in echocardiographic parameters (left ventricular parameters)
Changes in mitral insufficiency grade
Time frame: 24 months
Changes in mitral insufficiency grade assessed by transthoracic echocardiogram
Changes in serum NT-proB-Type natriuretic peptide (ng/l)
Time frame: 24 months
Changes in laboratory parameters (serum NT-proB-Type natriuretic peptide (ng/l)
Changes in Serum creatinine level (mg/dl)
Time frame: 24 months
Changes in laboratory parameters (Serum creatinine level (mg/dl)
Changes in glomerular filtration rate (ml/min)
Time frame: 24 months
Changes in laboratory parameters (glomerular filtration rate ml/min)
Changes in serum potassium level (mmol/l)
Time frame: 24 months
Changes in laboratory parameters (glomerular filtration rate ml/min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 39082399Boehmer AA, Schubert T, Rothe M, Keim C, Wiedenmann L, Ruckes C, von Stuelpnagel L, Theurl F, Schreinlechner M, Dobre BC, Kaess BM, Bauer A, Ehrlich JR. Angiotensin Receptor-Neprilysin Inhibitor Is Associated With Improved Cardiac Autonomic Function in Heart Failure. J Am Heart Assoc. 2024 Aug 6;13(15):e033538. doi: 10.1161/JAHA.123.033538. Epub 2024 Jul 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sacubitril/ valsartan in people with Heart Failure Patients, run by St. Josefs-Hospital Wiesbaden GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in heart rate variability (time frame: 24 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04587947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.