The Effectiveness of Sacubitril-Valsartan with ACEI/ARBs on Right Ventricular Function in Patients with Right Sided Heart Failure; A Randomized Clinical Controlled Trial
Comparison of the effectiveness of sacubitril-valsartan along with ACEI/ARB drugs on right ventricular function in patients with right heart failure
Design
Clinical trial with two arm parallel group,open label with simple randomization in phase 3 on 84 patients of right sided HF
Settings and conduct
Sampling will be done for patients with RV failure who require treatment with ARNI/ARB/ACEI admitted to Rasool Akram hospital or outpatient clinic for 3 months.in final selected groups , an echocardiography will be done by the related fellowship. treatment period will be started and patients will routinely be observed for their clinical status. another echo will be done at the end of the semestre. indexes related to RV function are going to be measured and then improvement of these indexes will be compared betweeen the groups by SPSS.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18, right sided heart failure
Exclusion criteria: GFR<30, Cr>2.5, SBP<100
Intervention groups
Intervention group: patients with right heart failure who receive Sacubitril valsartan.
control group 1: patients with right heart failure who receive Losartan.
control group2: patients with right heart failure who receive Captopril.
Main outcome variables
LV ejection fraction, RV dysfunction, RV diameter in diastole, LV end systolic and diastolic diameter, diastolic function of ventricles, RV-PA coupling, Pulmonary artery systolic pressure, fractional area change, function class of the patient.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230926059524N1
Registration date:2023-12-28, 1402/10/07
Registration timing:prospective
Last update:2023-12-28, 1402/10/07
Update count:0
Registration date
2023-12-28, 1402/10/07
Registrant information
Name
Elahe Zeinali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3422 6260
Email address
elahezeinali@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Sacubitril-Valsartan with ACEI/ARBs on Right Ventricular Function in Patients with Right Sided Heart Failure; A Randomized Clinical Controlled Trial
Public title
The Effect of Sacubitril-Valsartan on RV function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who aged over 18 years old
patients with any degree of right ventricular failure
written and informed consent
Exclusion criteria:
glomerular filteration rate less than 30 mg/dl
systolic blood pressure less than 100 mmHg
history of angioedema
right heart failure due to acute pulmonary emboli
creatinine more than 2.5mg/dl
renal artery stenosis
hisory of intolerance to the mentioned drugs
Death
Lack of consent to prticipate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial study, 84 patients with Right Sided Heart Failure will be included in the study. For random allocation of individuals in the study groups (intervention group and comparison group), the method of random allocation with block method (Block Randomization) will be used. In this method, blocks with a size of six (including three people in the intervention group and three people in the comparison group) with a ratio of 1:1 will be used (14 blocks of 6). Random Allocation software will be used to generate random sequences. The random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified on the cards and these cards are placed inside the sealed envelopes in order. In order to maintain the created sequence, the numbering will be recorded on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical science
At the beginning of the trial, 3 months after using the drug
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sacubitril valsartan (under the brand name: Artrestan, Arena Hayat co) with the starting dose of 50mg twice daily will be prescribed to patients with any degree of RV dysfunction on the condition of systolic blood pressure at more than 100mmHg, creatinine less than 2.5. on the follow up visits,the dose will be escalated to 100mg twice daily if the patient could tolerate that.at the end of the trimestre, the patients will have another echocardiography done again
Category
Treatment - Drugs
2
Description
Control group: Losartan(under the brand name: losartan, Zagros co.) with the starting dose of 25mg daily will be prescribed to patients with any degree of RV dysfunction on the condition of systolic blood pressure at more than 100mmHg, creatinine less than 2.5. on the follow up visits,the dose will be escalated to 50mg daily if the patient could tolerate that.at the end of the trimestre, the patients will have another echocardiography done again
Category
Treatment - Drugs
3
Description
Control group: Captopril (under the brand name: Tedapharm, Tehran Darou co.) with the starting dose of 6.25mg TDS will be prescribed to patients with any degree of RV dysfunction on the condition of systolic blood pressure at more than 100mmHg, creatinine less than 2.5. on the follow up visits,the dose will be escalated to 50mg TDS if the patient could tolerate that.at the end of the trimestre, the patients will have another echocardiography done again