Heart FailureNCT04185103
Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan
An observational study of Heart Failure, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 4 sites in Spain.
Trial summary
The aim of this study is to know if the Sacubitril-Valsartan treatment improves the T-wave alternans in those patients that begin its treatment, which would indirectly show a lower risk of malignant ventricular arrythmias. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sacubitril-Valsartan
- How many people
- 20 participants
- Where
- 4 sitesSpain
- Study dates
- 15 Oct 2019to 15 Dec 2020
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with heart failure that meet all of the following criteria and none of the exclusion criteria. The selection of patients to be included in the study will be made in accordance to the Sacubitril-Valsartan data sheet.
Who may be able to join
- Adults from 18 to 80 years old.
- Patients with grade II heart failure according to the New York Heart Association (NYHA).
- Left systolic disfunction: left ventricle ejection fraction<40%
- NT-proBNP > 600 pg/ml (or > 100 pg/ml in the case the patients has been hospitalised during the last year.
- Treated with ACE or ARA II+betablocker at stable doses during the prior 4 weeks to the beginning of the study.
Who cannot join
- Previously treated with Sacubitril-Valsartan.
- Allergy or intolerance to ARA II.
- Systolic blood pressure < 100 mmHG at inclusion.
- Glomerular Filtration <35 ml / min / 1.73 m2 of body surface.
- Level of potassium > 5,4 mEq/l.
- Impossibility to walk on a treadmill.
- Record of recovered sudden death or documented ventricular tachycardia.
- Carrier of an automatic implantable defibrillator.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites, 2 recruiting
- Not yet recruiting
Hospital de Alta Resolución de Sierra Norte
Constantina, Seville, 41450
Raquel Solanilla Rodriguez, Dr, 665082050, raquelsolanilla@hotmail.com
Dr
- Active, not recruiting
Hospital de Alta Resolución de Écija
Écija, Seville, 41400
- Active, not recruiting
Hospital de Alta Resolución de Lebrija
Lebrija, Seville, 41740
- Recruiting
Hospital de Alta Resolución de Utrera
Utrera, Sevilla, 41710
Antonio José Fernández Romero, 955 00 80 00, ajfr32@gmail.com
Antonio José Fernández Romero, Dr
About this study
The aim of this study is to know if the Sacubitril-Valsartan treatment improves the T-wave alternans in those patients that begin its treatment, which would indirectly show a lower risk of malignant ventricular arrythmias.
Read the detailed description
Sacubitril-Valsartan has shown to reduce sudden death in its principal clinical trial, PARADIGM-HF.
A T wave alternans (TWA) is an electrophysiological phenomenon that acts as an independent predictor of sudden death and ventricular arrhythmias in postinfarct myocardial.
TWA is measured by using a special software and electrodes during a treadmill test, that analyse small changes in the microvolt of the T wave consecutive with a complex algorithm in three dimensions. The TWA could be negative (normal), positive (pathological) or indeterminate. If a TWA is pathological it reflects an electric instability in depolarization.
Our hypothesis is that the treatment with Sacubitril-Valsartan in heart failure patients with reduced ejection fraction, could improved the TWA.
- Conditions
- Heart Failure
- Being tested
- Sacubitril-Valsartan
- Keywords
- Heart Failure, Sacubitril-Valsartan, T-wave changes alternans
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril-ValsartanDrug
After signing the Informed Consent, in the shortest possible time, the study investigator will carry out an ergometric test for the T-wave alternans (TWA) while still taking the basal medication. The patient will also sign the prototype Informed Consent for carrying out a stress test on a treadmill. It will also be carried out a basal life quality questionnaire, an analytical determination and a colour doppler echocardiography.
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril-Valsartan cohort | Patients with left systolic disfunction (left ventricle ejection fraction<40%) heart failure and diagnosed with grade II heart failure that have been treated with an ACE or ARA II+betablocker at stable doses during the last 4 weeks and after being evaluated by the cardiologist start Sacubitril-Valsartan treatment. Receives: Drug: Sacubitril-Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze the changes in the T-wave alternans
Comparison of the results in the same patient just before the beginning of the Sacubitril-Valsartan pharmacological treatment versus 6 months after its beginning, in patients with grade II heart failure and left systolic disfunction (left ventricle ejection fraction<40%).
Measured: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Secondary outcomes (3)
Evaluate the results in the life quality questionnaire.
Comparison of the life quality questionnaires results before and after the Sacubitril-Valsartan treatment.
Measured: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Study the levels of the n-terminal type B natriuretic propeptide
Comparison of the n-terminal type B natriuretic propeptide levels before and after the Sacubitril-Valsartan treatment.
Measured: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Evaluate the echocardiographic results
The echocardiographic results will be assessed by a combination of the measurement of the parameters: left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), left ventricular end systolic volume (LVESV) and left ventricle diastolic function, that will be compared before and after the Sacubitril-Valsartan treatment to evaluate its effect in patients with heart failure.
Measured: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start15 Oct 2019
- Primary completion15 Nov 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Sanitaria Bajo Guadalquivir
- Responsible party
- Sponsor
- Investigators
- Antonio José Fernández Romero, Dr, Principal investigator, Hospital de Alta Resolución de UtreraAntonio José Fernández Romero, Dr, Study chair, Hospital de Alta Resolución de Utrera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185103
- Sponsor's protocol ID
- FIS-SAC-2018-02
- Status last verified
- Dec 2019
- First submitted
- 12 Nov 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan
- ClinicalTrials.gov ID
- NCT04185103
- Acronym / sponsor ID
- FIS-SAC-2018-02
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Sacubitril-Valsartan, T-wave changes alternans
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Agencia Sanitaria Bajo Guadalquivir
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 4 Dec 2019 (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.
The aim of this study is to know if the Sacubitril-Valsartan treatment improves the T-wave alternans in those patients that begin its treatment, which would indirectly show a lower risk of malignant ventricular arrythmias.
Detailed description
Sacubitril-Valsartan has shown to reduce sudden death in its principal clinical trial, PARADIGM-HF.
A T wave alternans (TWA) is an electrophysiological phenomenon that acts as an independent predictor of sudden death and ventricular arrhythmias in postinfarct myocardial.
TWA is measured by using a special software and electrodes during a treadmill test, that analyse small changes in the microvolt of the T wave consecutive with a complex algorithm in three dimensions. The TWA could be negative (normal), positive (pathological) or indeterminate. If a TWA is pathological it reflects an electric instability in depolarization.
Our hypothesis is that the treatment with Sacubitril-Valsartan in heart failure patients with reduced ejection fraction, could improved the TWA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacubitril-Valsartan cohort | – | Drug: Sacubitril-ValsartanPatients with left systolic disfunction (left ventricle ejection fraction<40%) heart failure and diagnosed with grade II heart failure that have been treated with an ACE or ARA II+betablocker at stable doses during the last 4 weeks and after being evaluated by the cardiologist start Sacubitril-Valsartan treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with heart failure that meet all of the following criteria and none of the exclusion criteria. The selection of patients to be included in the study will be made in accordance to the Sacubitril-Valsartan data sheet.
Key inclusion criteria (5 listed)
- Adults from 18 to 80 years old.
- Patients with grade II heart failure according to the New York Heart Association (NYHA).
- Left systolic disfunction: left ventricle ejection fraction<40%
- NT-proBNP > 600 pg/ml (or > 100 pg/ml in the case the patients has been hospitalised during the last year.
- Treated with ACE or ARA II+betablocker at stable doses during the prior 4 weeks to the beginning of the study.
Key exclusion criteria (8 listed)
- Previously treated with Sacubitril-Valsartan.
- Allergy or intolerance to ARA II.
- Systolic blood pressure < 100 mmHG at inclusion.
- Glomerular Filtration <35 ml / min / 1.73 m2 of body surface.
- Level of potassium > 5,4 mEq/l.
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-ValsartanAfter signing the Informed Consent, in the shortest possible time, the study investigator will carry out an ergometric test for the T-wave alternans (TWA) while still taking the basal medication. The patient will also sign the prototype Informed Consent for carrying out a stress test on a treadmill. It will also be carried out a basal life quality questionnaire, an analytical determination and a colour doppler echocardiography. | Drug | Sacubitril-Valsartan cohort |
Primary outcome
Analyze the changes in the T-wave alternans
Time frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Comparison of the results in the same patient just before the beginning of the Sacubitril-Valsartan pharmacological treatment versus 6 months after its beginning, in patients with grade II heart failure and left systolic disfunction (left ventricle ejection fraction<40%).
3 secondary outcomes
Evaluate the results in the life quality questionnaire.
Time frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Study the levels of the n-terminal type B natriuretic propeptide
Time frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Evaluate the echocardiographic results
Time frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Antonio José Fernández Romero, Dr principal investigator
Hospital de Alta Resolución de Utrera
Antonio José Fernández Romero, Dr study chair
Hospital de Alta Resolución de Utrera
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 4 sites in Spain.
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 8 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: status not confirmed, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio José Fernández Romero, Dr (955 00 80 00, ajfr32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the changes in the T-wave alternans (time frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2019.